This study provides long-term follow-up of people who previously received a gene therapy called AAVAnc80-hOTOF for hearing loss caused by the otoferlin (OTOF) gene. Only participants who received this therapy into the cochlea in the AK-OTOF-101 clinical trial are eligible. Run by Akouos, Inc., this study does not use clinical phases and is enrolling by invitation.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Individuals with otoferlin gene-mediated hearing loss who received intracochlear administration of AAVAnc80-hOTOF in the AK-OTOF-101 Clinical Trial * Legally authorized representative and/or participant willingness to comply with all study requirements, as evidenced by successful completion of the informed consent process or permission and participant assent process (where appropriate) Exclusion Criteria: * Any condition that would not allow the potential participant to complete follow-up examinations during the course of the study and/or, in the opinion of the Investigator, makes the potential participant unsuitable for the study